FDA Inspection
Applied Consumer Services Inc.FDA Inspection 758746 - Applied Consumer Services Inc. - January 06, 2012
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Record Details
This FDA Inspection record concerns Applied Consumer Services Inc., with an inspection on January 6, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 9783706d-d990-4661-90d8-84078305f019
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 758746
- FDA center
- Human Drugs
- Project area
- Unapproved and Misbranded Drugs
FDA Citations
10- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.194(c)Testing and standardization of standards et. al.
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.182Written records kept in individual logs
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Other FDA inspections of Applied Consumer Services Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| September 29, 2025 | VAI | Florida District Office | Drug Quality Assurance |
| February 21, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 20, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 6, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |